A Study of the Safety and Efficacy of Posaconazole Versus Voriconazole for the Treatment of Invasive Aspergillosis (MK-5592-069)

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The purpose of this study is to evaluate the safety and efficacy of posaconazole (POS) versus voriconazole (VOR) in the treatment of adults and adolescents with invasive aspergillosis (IA). The primary hypothesis is that the all-cause mortality through Day 42 in the POS treatment group is non-inferior to that in the VOR treatment group.

Participants will start therapy with a posaconazole loading dose of 300 mg intravenously (IV) twice per day (BID) on Day 1, and then will receive posaconazole IV 300 mg once per day (QD) starting on Day 2 until clinically stable when participants will transition to oral therapy with posaconazole 300 mg tablets QD for up to a total of 12 weeks of treatment. Participants with renal insufficiency or without central venous catheter access may start study treatment with a loading dose of oral posaconazole 300 mg tablets BID on Day 1, and then 300 mg QD for up to a total of 12 weeks of treatment.

Drug: Posaconazole

Other Names:

SCH 056592

MK-5592

Noxafil®

Active Comparator: Voriconazole

Participants will start therapy with a voriconazole loading dose of 6 mg/kg of body weight IV BID on Day 1, and then will receive voriconazole IV 4 mg/kg of body weight IV BID starting on Day 2 until clinically stable when participants will transition to oral therapy with voriconazole 200 mg capsules BID for up to a total of 12 weeks of treatment. Participants with renal insufficiency or without central venous catheter access may start study treatment with a loading dose of oral voriconazole 300 mg capsules BID on Day 1, and then 200 mg BID for up to a total of 12 weeks of treatment.

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Layout table for eligibility information

Ages Eligible for Study:

13 Years and older (Child, Adult, Older Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Weight >40 kg (88 lb) and ≤150 kg (330 lb); if between 13 and 14 years of age must weigh >= 50 kg (110 lb)

Must meet the criteria for proven, probable, or possible IA. If with possible IA at time of randomization must be willing or be in process of an ongoing diagnostic work up which is anticipated to result in a mycological diagnosis of proven or probable IA post-randomization

Must have a central line (e.g., central venous catheter, peripherally-inserted central catheter, etc.) in place or planned to be in place prior to beginning IV study therapy. If without central catheter access, must be clinically stable and able to receive oral study therapy

Acute IA defined as duration of clinical syndrome of <30 days.

Female participants of child-bearing potential must be using a medically accepted method of birth control before beginning study-drug treatment and agree to continue its use for 30 days after stopping study medication